Belzutifan for Renal Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether belzutifan, an oral medication, can help control metastatic renal cell carcinoma (RCC) in patients under close monitoring without prior systemic treatment. Researchers aim to evaluate the medication's effectiveness and safety. Participants will either take belzutifan daily or undergo active surveillance by their doctors. Ideal candidates have had clear cell renal cancer with possible spread for less than a year and have not received specific cancer treatments before. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs that strongly affect liver enzymes (like St John's Wort or rifampicin) during the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.
Is there any evidence suggesting that belzutifan is likely to be safe for humans?
Research has shown that belzutifan is generally safe. In studies, most side effects were mild to moderate. Anemia, a common side effect, involves a low red blood cell count but was not severe for most participants. Few discontinued belzutifan due to side effects, indicating that many patients tolerate the treatment well. While more information is always helpful, current evidence suggests that belzutifan is reasonably safe for treating conditions like kidney cancer.12345
Why do researchers think this study treatment might be promising for renal cell carcinoma?
Researchers are excited about belzutifan for renal cell carcinoma because it offers a novel approach by targeting the hypoxia-inducible factor-2 alpha (HIF-2α) pathway. Unlike traditional treatments such as surgery, immunotherapy, or tyrosine kinase inhibitors that focus on removing or inhibiting cancer growth, belzutifan specifically disrupts cancer cell survival under low-oxygen conditions, which is common in tumors. This unique mechanism could potentially lead to more effective treatment outcomes with fewer side effects. Additionally, belzutifan is taken orally, offering a more convenient option compared to intravenous therapies.
What evidence suggests that belzutifan might be an effective treatment for renal cell carcinoma?
Studies have shown that belzutifan can help treat kidney cancer. In one study, about 22% of patients experienced a reduction or disappearance of their cancer. Another study found that 64% of patients had their disease stop progressing. Belzutifan has also been linked to longer periods where the disease does not worsen, allowing patients to live longer without their condition deteriorating. In this trial, participants in the treatment group will receive belzutifan, while those in the observation group will undergo active surveillance. Research suggests that treatments with belzutifan have been more effective than some current options, like cabozantinib, in controlling the disease.678910
Who Is on the Research Team?
Eric Jonasch, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with metastatic clear cell renal cell carcinoma, diagnosed within the last year and not previously treated systemically. Candidates must have adequate organ function, be suitable for active surveillance, and agree to use effective contraception. Exclusions include severe medical conditions, pregnancy or breastfeeding women, uncontrolled infections like HIV/HBV/HCV, known allergies to belzutifan components, brain metastases or leptomeningeal disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the treatment group take belzutifan by mouth every day, while those in the observation group undergo active surveillance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Belzutifan
Trial Overview
The BRAVE-RCC trial is testing whether belzutifan can control kidney cancer in patients who are candidates for active surveillance without previous systemic treatment. It's a study of both the effectiveness of belzutifan in managing the disease and its safety profile in these patients.
How Is the Trial Designed?
Participants will take belzutifan by mouth every day during the study. You will be given a dosing diary to write down when you take each dose of belzutifan, including if you miss or vomit any doses. Bring the diary with you to each visit, along with any leftover study drug and/or study drug bottles.
Participants will not receive treatment in this study. Instead, you will undergo active surveillance under the discretion of your treating physician.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
59: Real-World efficacy and safety of belzutifan in sporadic ...
The disease control rate was 64%. The median OS was 6.93 months (95% CI: 3.75-12.58). The median PFS was 3.09 months (95% CI 2.53-5.72). AEs of ...
Kidney cancer study shows improved outcomes for patients ...
The overall response rate was also higher with belzutifan, at 22% versus 3.5%, and 13 patients experienced a complete response with belzutifan ...
Belzutifan's role in the treatment landscape of clear cell ...
The major efficacy outcome measures were progression-free survival (PFS) and OS. Significant improvement in PFS was demonstrated for belzutifan ...
4.
onclive.com
onclive.com/view/belzutifan-based-combinations-meet-dfs-pfs-end-points-in-renal-cell-carcinomaBelzutifan-Based Combinations Meet DFS, PFS End ...
LITESPARK-011 and LITESPARK-022 trials showed significant PFS and DFS improvements in RCC with belzutifan combinations, surpassing cabozantinib ...
Updated Results From the Phase 2 LITESPARK-003 Study ...
In the initial analysis, the primary end point of objective response rate (ORR) was 57% in cohort 1 (n = 35) and 31% in cohort 2 (n = 52) after a median follow- ...
The safety profile of belzutifan in renal tumors - PubMed Central
While belzutifan's efficacy and side effect profile have been defined in clinical trials, data regarding its safety remain limited in the real- ...
The Safety Profile of Belzutifan in Renal Tumors
The efficacy and side effects of belzutifan are well-documented from clinical trials, however, real-world data examining the incidence and ...
Health-related quality of life with belzutifan versus ...
Belzutifan has a unique safety profile compared with other treatments for advanced renal cell carcinoma.5, 6, 7 For example, anaemia has also been observed ...
Belzutifan for Renal Cell Carcinoma in von Hippel–Lindau ...
Belzutifan was associated with predominantly grade 1 and 2 adverse events and showed activity in patients with renal cell carcinomas and non–renal cell ...
10.
cancertherapyadvisor.com
cancertherapyadvisor.com/reports/belzutifan-safety-profile-generally-manageable/Belzutifan Has “Generally Manageable” Safety Profile
Belzutifan has a “generally manageable” safety profile in patients with RCC, with a relatively low rate of treatment discontinuation.
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